Allogeneic Stem Cell Transplantation With 3-days Busulfan Plus Fludarabine as Conditioning in Patients With Relapsed or Refractory T-, NK/T-cell Lymphomas
Relapsed and refractory T-cell lymphomas have been reported to have dismal outcomes. The role of allogeneic stem cell transplantation have been demonstrated in these patients. This clinical trial is studying the efficacy and safety of busulfan plus fludarabine as conditioning therapy followed by allogeneic stem cell transplantation (Allo-SCT) in T- and NK/T-cell lymphoma patients who have relapsed or are refractory to previous chemotherapies including autologous transplantation.
• Age 19 - 65
• Histologically confirmed T or NK cell lymphomas :
‣ anaplastic large cell lymphoma
⁃ angioimmunoblastic T-cell lymphoma,
⁃ peripheral T-cell lymphoma, NOS
⁃ NK/T-cell lymphoma
• Relapsed after or refractory to one or more of previous chemotherapy including frontline autologous HSCT.
• At least one measured lesion using conventional CT or PET CT at the time of relapse after or refractory to one or more of previous chemotherapy and before salvage chemotherapy
• Complete or Partial response after short cycles of salvage chemotherapy
• Patients who have HLA full-match (8/8 in HLA-A, B, C, DR by DNA high-resolution technique) or one-locus mismatch (7/8) sibling, or unrelated bone marrow or peripheral blood or cord blood stem cell donors
• ECOG performance status ≤ 2
• Charlson Comorbidity Index (CCI) before HSCT ≤ 3
• Adequate renal function : serum creatinine level \< 2.0 mg/dL
⁃ Adequate liver function :
∙ Transaminase (AST/ALT) \< 3 X upper normal value (or \< 5 x ULN in the presence of lymphoma involvement of the liver)
‣ Total bilirubin \< 2 X upper normal value (or \< 5 x ULN in the presence of NK/T involvement of the liver)
⁃ Cardiac ejection fraction ≥ 50 % as measured by MUGA or 2D ECHO without clinically significant abnormality
⁃ No clinically significant infection
⁃ No clinically significant bleeding symptoms or sign
⁃ Patients who decided to participate in this study and signed for a written consent